UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028025
Receipt number R000032090
Scientific Title Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Date of disclosure of the study information 2017/07/01
Last modified on 2019/03/28 11:09:32

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Basic information

Public title

Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)

Acronym

Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)

Scientific Title

Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)

Scientific Title:Acronym

Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)

Region

Japan


Condition

Condition

burn, severe acute pancreatitis, sepsis

Classification by specialty

Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the clinical effects of continuous hemodiafiltration between using PMMA and AN69ST membrane hemofilter for the treatment of septic AKI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Changes of scores (SOFA, SAPS2, APACHE2, DIC score, CAI) at 48 and 72 hours after enrollment

Key secondary outcomes

-Duration of mechanical ventilation in 28 days
-Survival rate at 90 days
-ICU stay days
-Hospital stay days
-Changes of plasma lactate and IL-6 level at 72 hours after continuous hemodiafiltration
-Filter lifetime
-Total fluid volume


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Continuous hemodiafiltration using PMMA membrane hemofilter

Interventions/Control_2

Continuous hemodiafiltration using AN69ST membrane hemofilter

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

->=20 years of age
-Able and willing to provide informed consent
-Patients with burn, severe acute pancreatitis or sepsis
-Patients with KDIGO stage 1 screened
-Patients who require continuous hemodiafiltration for more than 24 hours

Key exclusion criteria

-Pregnant women
-Patients with chronic kidney disease or who received RRT before randomization
-Patients with terminal cancer
-Patients with body weight less than 30 kg
-Patients considered ineligible for the study by the investigator

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Sakurai

Organization

Faculty of Medicine, Saga University

Division name

Department of Emergency and Critical Care Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima, Saga City, Saga

TEL

0952-31-6511

Email

sr0737@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Sakurai

Organization

Faculty of Medicine, Saga University

Division name

Department of Emergency and Critical Care Medicine

Zip code

849-8501

Address

5-1-1 Nabeshima, Saga City, Saga

TEL

0952-31-6511

Homepage URL


Email

sr0737@cc.saga-u.ac.jp


Sponsor or person

Institute

Saga University

Institute

Department

Personal name



Funding Source

Organization

Toray Industries, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical research center, Saga University Hospital

Address

5-1-1 Nabeshima, Saga City, Saga

Tel

0952-34-3400

Email

clinstudycenter@mail.admin.saga-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

佐賀大学医学部附属病院(佐賀県)、唐津赤十字病院(佐賀県)、独立行政法人国立病院機構 嬉野医療センター(佐賀県)、佐賀県医療センター好生館(佐賀県)


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 02 Day

Date of IRB

2016 Year 05 Month 02 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 06 Month 30 Day

Last modified on

2019 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032090


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name